Effects of Intravenous Lidocaine Associated With Magnesium Sulfate on the Cisatracurium-Induced Neuromuscular Block
NCT ID: NCT02483611
Last Updated: 2016-01-15
Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-07-31
Study Completion Date
2015-09-30
Brief Summary
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The magnesium sulfate and lidocaine have been increasingly used alone or in combination during anesthesia procedure to meet various objectives, such as reduction of pain, use of smaller anesthetic doses and stabilization of hemodynamic parameters.
These medicines are often used in combination with neuromuscular blocking agents, which may contribute to the occurrence of residual block in some patients after anesthetic procedures. It was estimated that only 1-3 % of patients with residual block developing clinically apparent events. In a small proportion of patients, the consequences of residual blockade are very serious and even lethal. It is estimated that 40 % of patients with muscle paralysis come to the post-anesthesia care unit (PACU).
Considering that: (a) magnesium sulfate and lidocaine are showing an increasing number of applications in various areas of medicine, (b) these medications stand out for their properties analgesic, anti-inflammatory, anti-arrhythmic, neuroprotective and capable of reducing the demand of anesthetics and opioids, (c) magnesium sulfate as lidocaine has been important part of the therapeutic arsenal to control a large number of diseases (d) the patient surgical surgery or potentially have benefited in particular from its effects, (and) these drugs have been used routinely in many medical services as well as adjuvants in anesthesia, (f) previous studies have shown that magnesium sulfate is able to prolong the duration of neuromuscular blockade by different types of muscle relaxants, with controversies about its effect on latency (g) the effect of lidocaine on the action of muscle relaxants in current literature have shown great controversy and (h) do not exist in the literature studies involving both drugs; the investigators aimed to investigate the effects of magnesium sulphate infused alone or associated with lidocaine on the neuromuscular blockade promoted by cisatracurium, as well as evaluate its possible hemodynamic repercussions. For this purpose the SM was infused in bolus, prior to tracheal intubation and continuously during the maintenance of general anesthesia; the Lidocaine, when associated and the Isotonic Solution were used in the same way and timeline as SM. As secondary objectives it has been proposed to evaluate if the Lidocaine with Magnesium Sulfate would be able to interfere with the hemodynamic stability of the patients in the study.
These medicines are often used in combination with neuromuscular blocking agents, which may contribute to the occurrence of residual block in some patients after anesthetic procedures. It was estimated that only 1-3 % of patients with residual block developing clinically apparent events. In a small proportion of patients, the consequences of residual blockade are very serious and even lethal. It is estimated that 40 % of patients with muscle paralysis come to the post-anesthesia care unit (PACU).
Considering that: (a) magnesium sulfate and lidocaine are showing an increasing number of applications in various areas of medicine, (b) these medications stand out for their properties analgesic, anti-inflammatory, anti-arrhythmic, neuroprotective and capable of reducing the demand of anesthetics and opioids, (c) magnesium sulfate as lidocaine has been important part of the therapeutic arsenal to control a large number of diseases (d) the patient surgical surgery or potentially have benefited in particular from its effects, (and) these drugs have been used routinely in many medical services as well as adjuvants in anesthesia, (f) previous studies have shown that magnesium sulfate is able to prolong the duration of neuromuscular blockade by different types of muscle relaxants, with controversies about its effect on latency (g) the effect of lidocaine on the action of muscle relaxants in current literature have shown great controversy and (h) do not exist in the literature studies involving both drugs; the investigators aimed to investigate the effects of magnesium sulphate infused alone or associated with lidocaine on the neuromuscular blockade promoted by cisatracurium, as well as evaluate its possible hemodynamic repercussions. For this purpose the SM was infused in bolus, prior to tracheal intubation and continuously during the maintenance of general anesthesia; the Lidocaine, when associated and the Isotonic Solution were used in the same way and timeline as SM. As secondary objectives it has been proposed to evaluate if the Lidocaine with Magnesium Sulfate would be able to interfere with the hemodynamic stability of the patients in the study.
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Detailed Description
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The study was approved by the Medical Research Ethics Committee of the Hospital das Clinicas, of the Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Brazil; Its Unique Protocol ID is 5362/2013. This study was conducted with free written informed consent from the study subjects.
This report describes a prospective randomized clinical trial. The author states that the report includes every item in the checklist for a prospective randomized clinical trial.
The study was registered prior to patient enrollment. Forty-eight American Society of Anesthesiology patient classification status ASA I and II undergoing elective surgery were divided into three parallel groups. The M group received MS 40 mg.kg-1 as a bolus before the induction of anesthesia and 20mg.kg-1h-1 via continuous i.v. infusion during the operation period. The ML group received identical doses of MS combined with lidocaine 3 mg.kg-1 as a bolus before the induction of anesthesia and 3 mg.kg-1h-1 via continuous i.v. infusion during the operation period. The control group was administered a equivalent volume of isotonic solution. Anesthesia was maintained via propofol and remifentanil infusions. After loss of patient consciousness and administration of the bolus infusions, a 0.15 mg.kg-1 bolus of cisatracurium was administered to the patient over 5 s. No additional cisatracurium injections were performed. The patient's neuromuscular function was assessed every 15 s by measuring the adductor polis with a TOF Watch SX acceleromyograph. The primary endpoint was the time at which spontaneous recovery of a train-of-four (TOF) ratio of 90% as achieved. The systolic, diastolic and mean and heart rate were recorded and annotated at various times: M1- when the patient arrived in the operating room; M2- immediately before induction of anesthesia; M3- before the infusion of the tested solutions (saline, magnesium sulphate or magnesium sulphate associated with lidocaine); M4- five minutes after M3 (end of infusion loading dose of test solutions); M5 immediately before intubation; M6- one minute after tracheal intubation and M7 (a through f) - every fifteen minutes until the end of the study.
The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of the neuromuscular blockade (NMB). Quantitative variables were described as mean ± standard deviation. The normality of the distributions was tested for all variables in each group, using the non-parametric test of Shapiro-Wilk. When the variable normally distributed, we used the analysis of variance test (ANOVA) for comparison between groups. When differences were found between the groups, we used the Tukey test for multiple comparisons. When the variable is not normally distributed by applying the Shapiro-Wilk test, we used the Kruskal-Wallis test to compare the groups. When differences were found between the groups, we used the Dunn test for multiple comparisons. The critical level of significance was 5%.
During the analysis of the recovery characteristics of the neuromuscular blockade, all parameters based on the T1 response (DUR 25% DUR 75% and DUR 95%) were normalized considering the final T1 value when this response did not return to baseline (VIBY-MOGENSEN et al., 1996).
This report describes a prospective randomized clinical trial. The author states that the report includes every item in the checklist for a prospective randomized clinical trial.
The study was registered prior to patient enrollment. Forty-eight American Society of Anesthesiology patient classification status ASA I and II undergoing elective surgery were divided into three parallel groups. The M group received MS 40 mg.kg-1 as a bolus before the induction of anesthesia and 20mg.kg-1h-1 via continuous i.v. infusion during the operation period. The ML group received identical doses of MS combined with lidocaine 3 mg.kg-1 as a bolus before the induction of anesthesia and 3 mg.kg-1h-1 via continuous i.v. infusion during the operation period. The control group was administered a equivalent volume of isotonic solution. Anesthesia was maintained via propofol and remifentanil infusions. After loss of patient consciousness and administration of the bolus infusions, a 0.15 mg.kg-1 bolus of cisatracurium was administered to the patient over 5 s. No additional cisatracurium injections were performed. The patient's neuromuscular function was assessed every 15 s by measuring the adductor polis with a TOF Watch SX acceleromyograph. The primary endpoint was the time at which spontaneous recovery of a train-of-four (TOF) ratio of 90% as achieved. The systolic, diastolic and mean and heart rate were recorded and annotated at various times: M1- when the patient arrived in the operating room; M2- immediately before induction of anesthesia; M3- before the infusion of the tested solutions (saline, magnesium sulphate or magnesium sulphate associated with lidocaine); M4- five minutes after M3 (end of infusion loading dose of test solutions); M5 immediately before intubation; M6- one minute after tracheal intubation and M7 (a through f) - every fifteen minutes until the end of the study.
The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of the neuromuscular blockade (NMB). Quantitative variables were described as mean ± standard deviation. The normality of the distributions was tested for all variables in each group, using the non-parametric test of Shapiro-Wilk. When the variable normally distributed, we used the analysis of variance test (ANOVA) for comparison between groups. When differences were found between the groups, we used the Tukey test for multiple comparisons. When the variable is not normally distributed by applying the Shapiro-Wilk test, we used the Kruskal-Wallis test to compare the groups. When differences were found between the groups, we used the Dunn test for multiple comparisons. The critical level of significance was 5%.
During the analysis of the recovery characteristics of the neuromuscular blockade, all parameters based on the T1 response (DUR 25% DUR 75% and DUR 95%) were normalized considering the final T1 value when this response did not return to baseline (VIBY-MOGENSEN et al., 1996).
Conditions
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Neuromuscular Block
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Group M
Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery.
After the bolus of magnesium sulfate, 0.15 mg/kg of cisatracurium was infused over 5 seconds.
Group Type
EXPERIMENTAL
Magnesium Sulfate
Intervention Type
DRUG
Cisatracurium
Intervention Type
DRUG
Group ML
Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery.
After the bolus of magnesium sulfate and lidocaine, 0.15 mg/kg of cisatracurium was infused over 5 seconds
Group Type
EXPERIMENTAL
Magnesium Sulfate
Intervention Type
DRUG
Lidocaine
Intervention Type
DRUG
Cisatracurium
Intervention Type
DRUG
Group C
Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups.
After the bolus of the isotonic solution , 0.15 mg/kg of cisatracurium was infused over 5 seconds
Group Type
PLACEBO_COMPARATOR
Isotonic Solution
Intervention Type
DRUG
Cisatracurium
Intervention Type
DRUG
Interventions
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Magnesium Sulfate
Intervention Type
DRUG
Lidocaine
Intervention Type
DRUG
Isotonic Solution
Intervention Type
DRUG
Cisatracurium
Intervention Type
DRUG
Other Intervention Names
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Nimbex
Eligibility Criteria
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Inclusion Criteria
* ASA I or II
* BMI between 18 and 29
* BMI between 18 and 29
Exclusion Criteria
* Use of medications that could affect the neuromuscular blockade such as calcium channel inhibitors, anticonvulsants and lithium carbonate
* Presence of neuromuscular, renal or hepatic dysfunction.
* Hypermetabolic or hypometabolic states such as fever, infection, and hyperthyroidism or hypothyroidism
* Acid-base disorder, congestive heart failure or conductive heart problems, and those who were being treated for cardiac arrhythmias
* Presence of neuromuscular, renal or hepatic dysfunction.
* Hypermetabolic or hypometabolic states such as fever, infection, and hyperthyroidism or hypothyroidism
* Acid-base disorder, congestive heart failure or conductive heart problems, and those who were being treated for cardiac arrhythmias
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Sao Paulo
OTHER
Sponsor Role
lead
Responsible Party
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Waynice N.P. Garcia
M.D., Ph.D
Responsibility Role
PRINCIPAL_INVESTIGATOR
References
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Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.
Reference Type
BACKGROUND
Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.
Reference Type
BACKGROUND
Kim MH, Oh AY, Jeon YT, Hwang JW, Do SH. A randomised controlled trial comparing rocuronium priming, magnesium pre-treatment and a combination of the two methods. Anaesthesia. 2012 Jul;67(7):748-54. doi: 10.1111/j.1365-2044.2012.07102.x. Epub 2012 Mar 15.
Reference Type
BACKGROUND
Habe K, Kawasaki T, Sata T. [A case of prolongation of rocuronium neuromuscular blockade in a pregnant patient receiving magnesium]. Masui. 2014 Jul;63(7):817-9. Japanese.
Reference Type
BACKGROUND
Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.
Reference Type
BACKGROUND
Hans GA, Defresne A, Ki B, Bonhomme V, Kaba A, Legrain C, Brichant JF, Hans PC. Effect of an intravenous infusion of lidocaine on cisatracurium-induced neuromuscular block duration: a randomized-controlled trial. Acta Anaesthesiol Scand. 2010 Nov;54(10):1192-6. doi: 10.1111/j.1399-6576.2010.02304.x. Epub 2010 Sep 14.
Reference Type
BACKGROUND
Kim MH, Oh AY, Han SH, Kim JH, Hwang JW, Jeon YT. The effect of magnesium sulphate on intubating condition for rapid-sequence intubation: a randomized controlled trial. J Clin Anesth. 2015 Nov;27(7):595-601. doi: 10.1016/j.jclinane.2015.07.002. Epub 2015 Aug 25.
Reference Type
BACKGROUND
Shahrami A, Assarzadegan F, Hatamabadi HR, Asgarzadeh M, Sarehbandi B, Asgarzadeh S. Comparison of therapeutic effects of magnesium sulfate vs. dexamethasone/metoclopramide on alleviating acute migraine headache. J Emerg Med. 2015 Jan;48(1):69-76. doi: 10.1016/j.jemermed.2014.06.055. Epub 2014 Sep 30.
Reference Type
BACKGROUND
Ventham NT, Kennedy ED, Brady RR, Paterson HM, Speake D, Foo I, Fearon KC. Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. World J Surg. 2015 Sep;39(9):2220-34. doi: 10.1007/s00268-015-3105-6.
Reference Type
BACKGROUND
Govindarajan R, Shah A, Reddy VS, Parithivel V, Ravikumar S, Livingstone D. Improving the functionality of intra-operative nerve monitoring during thyroid surgery: is lidocaine an option? J Clin Med Res. 2015 Apr;7(4):282-5. doi: 10.14740/jocmr2025w. Epub 2015 Feb 9.
Reference Type
BACKGROUND
Czarnetzki C, Lysakowski C, Elia N, Tramer MR. Time course of rocuronium-induced neuromuscular block after pre-treatment with magnesium sulphate: a randomised study. Acta Anaesthesiol Scand. 2010 Mar;54(3):299-306. doi: 10.1111/j.1399-6576.2009.02160.x. Epub 2009 Nov 16.
Reference Type
RESULT
Czarnetzki C, Lysakowski C, Elia N, Tramer MR. Intravenous lidocaine has no impact on rocuronium-induced neuromuscular block. Randomised study. Acta Anaesthesiol Scand. 2012 Apr;56(4):474-81. doi: 10.1111/j.1399-6576.2011.02625.x. Epub 2012 Jan 19.
Reference Type
RESULT
Hans GA, Bosenge B, Bonhomme VL, Brichant JF, Venneman IM, Hans PC. Intravenous magnesium re-establishes neuromuscular block after spontaneous recovery from an intubating dose of rocuronium: a randomised controlled trial. Eur J Anaesthesiol. 2012 Feb;29(2):95-9. doi: 10.1097/EJA.0b013e32834e13a6.
Reference Type
RESULT
Kim SH, So KY, Jung KT. Effect of magnesium sulfate pretreatment on onset and recovery characteristics of cisatracurium. Korean J Anesthesiol. 2012 Jun;62(6):518-23. doi: 10.4097/kjae.2012.62.6.518. Epub 2012 Jun 19.
Reference Type
RESULT
Kussman B, Shorten G, Uppington J, Comunale ME. Administration of magnesium sulphate before rocuronium: effects on speed of onset and duration of neuromuscular block. Br J Anaesth. 1997 Jul;79(1):122-4. doi: 10.1093/bja/79.1.122.
Reference Type
RESULT
Cardoso LS, Martins CR, Tardelli MA. Effects of intravenous lidocaine on the pharmacodynamics of rocuronium. Rev Bras Anestesiol. 2005 Aug;55(4):371-80. doi: 10.1590/s0034-70942005000400001. English, Portuguese.
Reference Type
RESULT
Nonaka A, Sugawara T, Suzuki S, Masamune T, Kumazawa T. [Pretreatment with lidocaine accelerates onset of vecuronium-induced neuromuscular blockade]. Masui. 2002 Aug;51(8):880-3. Japanese.
Reference Type
RESULT
Vivancos GG, Klamt JG, Garcia LV. Effects of 2 mg.kg(-)(1) of intravenous lidocaine on the latency of two different doses of rocuronium and on the hemodynamic response to orotracheal intubation. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):1-12. doi: 10.1016/S0034-7094(11)70001-0.
Reference Type
RESULT
Ghodraty MR, Saif AA, Kholdebarin AR, Rokhtabnak F, Pournajafian AR, Nikzad-Jamnani AR, Shah A, Nader ND. The effects of magnesium sulfate on neuromuscular blockade by cisatracurium during induction of anesthesia. J Anesth. 2012 Dec;26(6):858-63. doi: 10.1007/s00540-012-1439-x. Epub 2012 Jul 3.
Reference Type
RESULT
Rotava P, Cavalcanti IL, Barrucand L, Vane LA, Vercosa N. Effects of magnesium sulphate on the pharmacodynamics of rocuronium in patients aged 60 years and older: A randomised trial. Eur J Anaesthesiol. 2013 Oct;30(10):599-604. doi: 10.1097/EJA.0b013e328361d342.
Reference Type
RESULT
Gupta K, Vohra V, Sood J. The role of magnesium as an adjuvant during general anaesthesia. Anaesthesia. 2006 Nov;61(11):1058-63. doi: 10.1111/j.1365-2044.2006.04801.x.
Reference Type
RESULT
McCoy EP, Connolly FM, Mirakhur RK, Loan PB, Paxton LD. Nondepolarizing neuromuscular blocking drugs and train-of-four fade. Can J Anaesth. 1995 Mar;42(3):213-6. doi: 10.1007/BF03010679.
Reference Type
RESULT
Viby-Mogensen J, Jorgensen BC, Ording H. Residual curarization in the recovery room. Anesthesiology. 1979 Jun;50(6):539-41. doi: 10.1097/00000542-197906000-00014. No abstract available.
Reference Type
RESULT
Kopman AF, Kumar S, Klewicka MM, Neuman GG. The staircase phenomenon: implications for monitoring of neuromuscular transmission. Anesthesiology. 2001 Aug;95(2):403-7. doi: 10.1097/00000542-200108000-00023.
Reference Type
RESULT
Staals LM, Driessen JJ, Van Egmond J, De Boer HD, Klimek M, Flockton EA, Snoeck MM. Train-of-four ratio recovery often precedes twitch recovery when neuromuscular block is reversed by sugammadex. Acta Anaesthesiol Scand. 2011 Jul;55(6):700-7. doi: 10.1111/j.1399-6576.2011.02448.x. Epub 2011 May 16.
Reference Type
RESULT
Katz RL, Gissen AJ. Effects of intravenous and intra-arterial procaine and lidocaine on neuromuscular transmission in man. Acta Anaesthesiol Scand Suppl. 1969;36:103-13. doi: 10.1111/j.1399-6576.1969.tb00482.x. No abstract available.
Reference Type
RESULT
Matsuo S, Rao DB, Chaudry I, Foldes FF. Interaction of muscle relaxants and local anesthetics at the neuromuscular junction. Anesth Analg. 1978 Sep-Oct;57(5):580-7. doi: 10.1213/00000539-197809000-00014.
Reference Type
RESULT
Toft P, Kirkegaard Nielsen H, Severinsen I, Helbo-Hansen HS. Effect of epidurally administered bupivacaine on atracurium-induced neuromuscular blockade. Acta Anaesthesiol Scand. 1990 Nov;34(8):649-52. doi: 10.1111/j.1399-6576.1990.tb03165.x.
Reference Type
RESULT
Loyola YC, Braga Ade F, Poterio GM, Sousa SR, Fernandes SC, Braga FS. [Influence of lidocaine on the neuromuscular block produced by rocuronium: study in rat phrenic-diaphragmatic nerve preparation.]. Rev Bras Anestesiol. 2006 Apr;56(2):147-56. doi: 10.1590/s0034-70942006000200006. Portuguese.
Reference Type
RESULT
Germano Filho PA, Cavalcanti IL, Barrucand L, Vercosa N. Effect of magnesium sulphate on sugammadex reversal time for neuromuscular blockade: a randomised controlled study. Anaesthesia. 2015 Aug;70(8):956-61. doi: 10.1111/anae.12987. Epub 2015 Apr 1.
Reference Type
RESULT
Paula-Garcia WN, Oliveira-Paula GH, de Boer HD, Garcia LV. Lidocaine combined with magnesium sulfate preserved hemodynamic stability during general anesthesia without prolonging neuromuscular blockade: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2021 Mar 27;21(1):91. doi: 10.1186/s12871-021-01311-y.
Reference Type
DERIVED
Other Identifiers
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15541213.3.0000.5440
Identifier Type: REGISTRY
Identifier Source: secondary_id
5362/2013
Identifier Type: -
Identifier Source: org_study_id
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